Chronic Lymphocytic Leukemia (CLL) : Gazyva in combination with chlorambucil is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia. Follicular Lymphoma (FL) : Gazyva in combination with chemotherapy, followed ... Read more Chronic Lymphocytic Leukemia (CLL) : Gazyva in combination with chlorambucil is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia. Follicular Lymphoma (FL) : Gazyva in combination with chemotherapy, followed by Gazyva maintenance is indicated for the treatment of patients with previously untreated follicular lymphoma. Gazyva in combination with bendamustine, followed by Gazyva maintenance, is indicated for the treatment of patients with FL who did not respond to, or who progressed during or after treatment with rituximab or a rituximab-containing regimen.
Obinutuzumab is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B lymphocytes. Upon binding to CD20, obinutuzumab mediates B-cell lysisthrough (1) engagement of immune effector cells (2) by directly activating intracellular death signaling pathways (direct cell death), and/or (3) activation of the complement cascade. The immune effector cell mechanisms include antibody-dependent cellular cytotoxicity (ADCC) and antibodydependent cellular phagocytosis. As an antibody with reduced fucose content, obinutuzumab induces greater ADCC activity than rituximab in vitro using human cancer cell lines. Obinutuzumab also demonstrated an increased ability to induce direct cell death when compared to rituximab. Obinutuzumab binds to FcγRIII using purified proteins with a higher affinity than rituximab. Obinutuzumab and rituximab bind with similar affinity to overlapping epitopes on CD20.
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The following adverse reactions are discussed in greater detail in other sections of the label: Hepatitis B reactivation Progressive multifocal leukoencephalopathy Infusion reactions Tumor lysis syndrome Infections Neutropenia Thrombocytopenia
Obinutuzumab is contraindicated in patients with a known hypersensitivity to obinutuzumab or to any of the excipients.
No formal drug-drug interaction studies have been performed, although limited drug interaction sub-studies have been undertaken for Gazyva with bendamustine, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone), FC (fludarabine, cyclophosphamide) and chlorambucil. Co administration with Gazyva had no effect on the pharmacokinetics of bendamustine, FC or the individual components of CHOP; in addition, there were no apparent effects of bendamustine, FC, chlorambucil or CHOP on the pharmacokinetics of Gazyva. A risk for interactions with concomitantly used medicinal products cannot be excluded.
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